HARTFORD — - The surgery was supposed to repair the patient's heart, but more than five hours into the procedure, something went wrong — a "catastrophic" failure of the pump meant to keep blood and oxygen flowing through the patient's body. The patient sustained a brain injury and died a month later.

But that wasn't the only thing that went wrong at St. Francis Hospital and Medical Center after the device failed, according to state health officials.

Under federal law and hospital policy, the hospital should have notified the federal government or the device manufacturer of the problem, but that did not happen, according to an investigation report by state regulators. Hospital policy called for the device to be impounded and for the director of clinical engineering to be notified without delay, but he wasn't told for more than two weeks, the report said. And, it stated, the device itself was put back into use within three to four days, even though it had not been examined by the required staff.

PDF: St. Francis Violations

The problems following the device failure were among numerous violations cited by state health officials, who on Thursday placed St. Francis on probation for one year.

Regulators also cited problems with hospital facilities, inadequate preventive maintenance of medical equipment, and a lack of evidence that staff evaluated the neurological signs of a patient who fell out of bed and sustained a head injury. The patient later died.

Under a consent order signed Thursday, the hospital will be required to take corrective action including additional staff training and submitting to a review by an outside consultant.

In a statement Thursday afternoon, St. Francis officials said the hospital has already been working with the state health department on improvements.

In July, shortly after the cardiac patient died, St. Francis voluntarily suspended its non-emergency cardiac surgeries at the recommendation of the state health department. The suspension was lifted the following week after the department determined that safety concerns had been corrected, but the department continued investigating the hospital.

Said the hospital: "Throughout the hospital there have been aggressive actions taken, including new reporting responsibilities, administrative changes, updated operating room procedures, and revised equipment inspection and maintenance policies, all to help ensure the superior patient care that is our highest priority. Saint Francis wishes to extend our deepest sympathies to the family of the patient who passed away following surgery that prompted this review of our policies, procedures, and administrative protocols."

In the investigation report, state regulators wrote that in the case of the cardiac patient, the hospital's medical staff and governing body "failed to assume full accountability and responsibility for ensuring patient safety and quality of care."

The commission that accredits hospitals has a policy that when a patient dies unexpectedly there should be a comprehensive analysis of the incident involving those with the most knowledge of the event. But in the case of the cardiac patient, the surgeon, anesthesiologist and physician assistant were not part of the analysis, according to the state report.

"The hospital lacked a mechanism to process critical incidents effectively and expeditiously in order to ensure patient safety," the report said.

The report also noted problems in the hospital's preventive maintenance of medical equipment. Interviews with the director of clinical engineering indicated that the department was short-staffed and did not ask for resources to keep up with the required preventive maintenance, the report said.

The investigation report also cited several problems with hospital facilities.

In the hospital kitchen, food carts were laden with debris, blankets were absorbing food juices and runoff in a food cart near the ovens, and boxes of frozen bacon were moved from the floor to a cooking surface, the report stated.

In the newborn intensive care unit, a freezer that contained breast milk was consistently at temperatures outside the normal range and the manager was not aware of any problems, according to the report.

Meanwhile, the report said, numerous staff members in operating suites were wearing head coverings that failed to completely cover their hair, even while they were directly over or within direct contact of the surgical sites.

And surgical equipment was being stored in the "soiled utility and biohazard trash" room inside the main operating suite, the report stated.

Reprinted with permission of the Hartford Courant.
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